Wednesday, May 26, 2010

It was my privilege to address the audience at the Tobacco Merchants Association (TMA) annual conference yesterday in Williamsburg, Virginia, along with a panel of other public health experts in tobacco control, including Dr. Joel Nitzkin, Dr. Carl Phillips, and Dr. Brad Rodu.

The most interesting thing about the conference, to me, was the desire of the TMA to hear specifically from experts in public health and to air the presentation of views that may be contrary to many of its members. This is quite unlike my recent experiences at tobacco control conferences, where only one view on the issues is allowed, and dissenting views are suppressed.

Our panel, which focused on the issue of science-based policy making and FDA regulation of tobacco products, was preceded by yesterday's talk by Dr. Lawrence Deyton, the director of the FDA's Center for Tobacco Products, reported on here by John Reid Blackwell and Dave Ress of the Richmond Times-Dispatch. Dr. Deyton expressed to the Association members a desire to enter into a dialogue on the issues, although he also warned them that the Agency would take firm action against companies that do not fully cooperate with Agency regulations. He also emphasized the Agency's commitment to science-based policy.

My talk focused on the modified risk products provisions of the FDA Tobacco Act (section 911) and whether or not these provisions were science-based. I pointed out that there are two possible pathways for modified risk tobacco products: the reduced risk pathway and the reduced exposure pathway. Reduced risk products are those for which the manufacturer wishes to claim that the product is safer than other products on the market. Reduced exposure products are those for which the manufacturer will not make any explicit health claim, but will merely inform consumers that it contains less of a certain constituent, or is free of a particular constituent.

For the reduced risk pathway, the manufacturer must show that the product will reduce health risks to individual users. I argued that this is a very high scientific standard, one that can only be met through long-term epidemiologic studies with thousands of product users in order to establish the long-term relative risks of using these products.

However, this produces a catch-22 situation: A manufacturer cannot market a product until it demonstrates that it reduces individual risk. But a manufacturer cannot demonstrate that the product reduces individual risk unless it first markets the product.

Thus, it is virtually, if not literally impossible for any reduced risk product ever to be approved by the FDA.

For the reduced exposure pathway, the manufacturer need only show that the product does indeed decrease exposure to a particular constituent or constituents and that a corresponding reduction in health risk is "reasonably likely." This is possible to do with laboratory studies, so it is feasible to make the necessary demonstrations to the Agency.

However, there is a third requirement: the manufacturer must show that as it plans to package and market the product, consumers will not believe that the product reduces their risk. In other words, even though consumers know that the product reduces exposure, they must not believe that it reduces risk.

This, again, creates a nearly impossible task. If consumers are aware that a product reduces exposure to one or more harmful substances, they are naturally going to believe that it reduces their risk of disease. The only way to avoid this perception would be not to tell consumers that the product reduces exposure. But in that case, the product is no longer a reduced exposure product and so it cannot be approved for marketing in the United States.

Thus, the FDA Tobacco Act creates another catch-22: A manufacturer cannot market a product as reduced exposure unless it can show that consumers will not perceive it to be less harmful. But consumers will only perceive that the product is not any less harmful if it is not marketed as reduced exposure.

This provision, in other words, makes it virtually, if not literally impossible to market a reduced exposure product. One would have to make very limited claims that do not result in consumers believing the product is any safer. But if consumers don't believe the product is any safer, then why would they want to switch to that product?

The rest of the story is that the Act simply makes no sense. It is essentially a hoax, designed to make it look like the policy makers and health groups are interested in protecting the health of smokers, but instead, if you actually read the fine print, you'll find that the law sacrifices the health of smokers by making it impossible for tobacco companies or public health groups to pursue a harm reduction strategy.

This is not science-based policy. It is protectionism. Protection of the status quo. Protection of the existing tobacco market. The anti-smoking groups are not interested in actually protecting the health of smokers by encouraging them to use potentially less harmful alternatives. Instead, they are protecting the highest risk products and making sure that smokers continue smoking these high-risk products and that they do not switch to products that could potentially save their lives, or at least greatly reduce their risk of disease.

Monday, May 24, 2010

The North Carolina Alliance for Health - which includes the state chapters of the American Lung Association, American Heart Association, and American Cancer Society - issued a press release in which it expressed an interest in and commitment to the preservation of current levels of cigarette tax revenues.

In the press release, the Alliance boasted that despite claims by some opponents, increasing cigarette taxes will not result in large decreases in revenues over time because cigarette smoking will only drop by a little bit, thus maintaining the cigarette revenue stream over time.

According to the press release: "As the legislative session begins, a report released today by a tobacco policy expert at the University of Illinois at Chicago confirms that a significant cigarette tax increase in North Carolina will produce a large, sustained increase in state tobacco tax revenues. Several states, including South Carolina, have recently raised tobacco taxes to deal with budget shortfalls. "This report joins the mountain of evidence showing why raising the cigarette tax is exactly what North Carolina needs to help tackle our budget problems," said Pam Seamans, Executive Director of the North Carolina Alliance for Health. "As we saw last week in South Carolina more states are increasing the cigarette tax to raise revenue and protect vital programs like education and law enforcement from deep cuts, while preventing kids from smoking and saving lives at the same time," she said." ...

"To maintain, or even increase, our cigarette tax revenues over time, North Carolina can take a number of additional actions, in addition to periodically increasing the cigarette tax rates," said Pam Seamans, Executive Director of the North Carolina Alliance for Health. "We are one of only three states that does not have a tax stamp on cigarettes and could implement high-tech tax stamp to ensure that taxes are paid and to prevent cigarette smuggling and tax evasion," she said. "This will become especially important now that South Carolina has increased its cigarette tax to 57 cents."

The Rest of the Story

This press release from the North Carolina Alliance for Health is quite revealing. Instead of calling on measures to substantially reduce cigarette smoking so that cigarette tax revenues decline over time, the Alliance is instead committed to making sure that cigarette consumption does not drop too much, thereby threatening cigarette revenues.

It seems disturbing to me that a coalition of groups whose interest is supposed to be in protecting the public's health is instead primarily interested in using cigarette smokers as a source of funding for state programs and is committed to preserving the level of cigarette smoking so as not to threaten that funding.

This story reveals one of the chief problems associated with the anti-smoking groups' indiscriminate and knee-jerk support for all cigarette tax increases: the use of cigarette tax revenue to fund essential government programs makes the state dependent upon continued smoking to fund those programs, and it removes any incentive for programs that would substantially reduce smoking levels.

If the Alliance wanted to promote a program in North Carolina that would substantially reduce cigarette smoking, it can no longer do it because it has now committed itself to preserving the level of cigarette tax revenue in the state. That goal is simply not consistent with a goal of seriously reducing smoking rates. You can't have it both ways.

But having it both ways is exactly what the North Carolina Alliance for Health - and most of the other anti-smoking groups in the country - are trying to do. On the one hand, they argue the need to raise cigarette taxes in every state in order to fund essential government programs. On the other hand, they are unwilling to support major initiatives that would make a serious dent in smoking, and therefore threaten the tax initiatives they are supporting.

In doing so, these "anti-smoking" groups are actually acting like groups whose primary priority is to preserve levels of cigarette consumption, rather than to decrease them.

What these groups are saying is: "We want to raise cigarette taxes because it's a politically easy and popular victory which will make us feel good and make it easy for us to say that we're doing something to reduce cigarette consumption. But fortunately, the impact on smoking is quite small, and these tax initiatives won't seriously put a dent in cigarette consumption. We will spend our time and resources working on the limited initiative - taxation - which creates a quick and easy political victory. But we won't devote our time and resources to true health reform, which would substantially reduce cigarette smoking."

The rest of the story is that when it really comes down to it, these anti-smoking groups don't really want to seriously reduce cigarette smoking. What they want is to have cigarette smokers continue to smoke, thus allowing these groups to take advantage of those smokers - and the tax revenues that they generate - for political gain and feel-good victories for these health groups.

It truly is a "win, win" proposition for the anti-smoking groups. On the one hand, they score an easy political victory on the backs of smokers, being able to say that they are doing something and raising revenue at the same time. On the other hand, they obviate the need the do something meaningful to substantially reduce smoking rates in their state. Doing so would threaten the very programs that are being supported by these tax increases.

With their knee-jerk support for cigarette taxes as a source of revenue to close budget shortfalls, the anti-smoking groups are making the state - and themselves - dependent on continued high levels of cigarette smoking.

Smokers are quickly becoming critical supporters of state government. Without them, the budget collapses. The biggest winner? The tobacco companies, which profit from the essential end to any threat of major reductions in consumption of their products.

Thursday, May 20, 2010

A new study published online ahead of print in the American Journal of Public Health concludes that the statewide smoking ban in Arizona caused a reduction in acute myocardial infarction [AMI] (heart attack) admissions in the state (see: Herman PM, Walsh ME. Hospital admissions for acute myocardial infarction, angina, stroke, and asthma after implementation of Arizona's comprehensive statewide smoking ban. American Journal of Public Health 2010).

The study methods were as follows: "We compared monthly hospital admissions from January 2004 through May 2008 for these primary diagnoses and 4 diagnoses not associated with SHS [secondhand smoke] (appendicitis, kidney stones, acute cholecystitis, and ulcers) for Arizona counties with preexisting county or municipal smoking bans and counties with no previous bans. We attributed reductions in admissions to the statewide ban if they occurred only in diagnoses associated with SHS and if they were larger in counties with no previous bans."

The results were reported as follows: "Statistically significant reductions in hospital admissions were seen for AMI, angina, stroke, and asthma in counties with no previous bans over whatwas seen in counties with previous bans."

The authors also conclude that the smoking ban resulted in a cost savings of $16.8 million during its first 13 months due to reduced hospital admissions for cardiovascular disease and asthma.

The Rest of the Story

Although it would be a wonderful thing if the smoking ban led to such a drastic decline in cardiovascular disease admissions, the problem is that for 83% of the state's population, there was a significant increase in heart attacks associated with the implementation of the statewide smoking ban, according to the study.

For the counties in which a workplace smoking ban, but not necessarily a bar or restaurant smoking ban, was in place in at least one city during the period 2004-2007 -- which make up 83% of Arizona's population -- the study fails to find any decline in heart attacks. In fact, it reports a significant increase in heart attacks associated with the implementation of the statewide smoking ban in 2007-2008 (see Figure 1a). In these counties, the rate of heart attack admissions - which had been steadily dropping prior to the smoking ban - actually started to increase after the statewide smoking ban. And again, these counties cover the overwhelming majority of the state's population.

While the investigators appear to dismiss this problem by arguing that the statewide smoking ban would not be expected to lower heart attacks in the "ban counties" because they already had smoking bans in place, this explanation is not plausible. The ban counties were those which merely had to have one city with just a workplace smoking law. These are not counties which had stringent, comprehensive smoking bans that included all hospitality establishments, like restaurants and bars. Exposure to secondhand smoke in typical workplaces (non-hospitality workplaces) is quite low and one would not expect that a workplace smoking ban that excluded bars and restaurants would have much effect on reducing secondhand smoke exposure.

Moreover, the extension of these bans to include bars and restaurants would - according to the conclusions of anti-smoking groups - result in a significant decline in heart attacks.

By including any smoking bans, not just meaningful laws that eliminate smoking in bars and/or restaurants, in the comparison group, the study managed to produce an "intervention" group that was terribly unrepresentative. These were communities that were so far behind the times (and probably, with a large proportion of smokers in their populations) that not a single city in their jurisdictions had even enacted a law to protect workers in office workplaces.

In fact, the study acknowledges that the division of counties into "ban counties" and "non-ban counties" was essentially a division of counties into "urban" versus "rural" regions, respectively. There are so many other differences between urban and rural regions that one cannot validly use urban regions as a comparison group to estimate the secular trends in heart attacks in rural regions. But this is exactly what this study did.

The flaw of the study, then, is that it used a comparison group that was not comparable. It used urban regions as a comparison group to estimate the baseline trends in heart attacks in rural regions. The lack of similarity between these groups renders the study methodology flawed.

There are a number of reasons why rural regions would be expected to lag behind urban regions in terms of the secular decline in cardiovascular disease that has been observed in recent years. Differences in access to treatment, higher smoking rates, and differences in other risk factors for cardiovascular disease would all be expected to play a role. What we are possibly observing in this study -- and a plausible, alternative explanation for the findings that the study cannot rule out -- is that cardiovascular disease improvements that had already occurred in urban areas started to finally spread to rural regions. The main point is that the study is not capable of ruling out this possibility; thus, it cannot validly conclude that the observed decline in cardiovascular disease in the rural areas was attributable to the statewide smoking ban.

What is interesting to me is that although the study attributes the decline in heart attacks in rural regions to the smoking ban, it refuses to attribute the increase in heart attacks observed in urbane regions to the smoking ban. Conveniently, it offers another explanation: there must be some other factor involved.

But if there is some other factor that explains the increase in heart attacks in urban regions, could not that same other factor explain the decrease in heart attacks in rural regions. You can't set forward a method and that reject that method when the findings don't come out the way you would like. But that's exactly what this study does.

The study argues: "The statistically significant increase seen in AMI would be even harder to explain as being caused by the statewide ban. ... These changes are likely because of an increase in causal factors for AMI or for its diagnosis other than the statewide ban."

In other words, the observed effects in rural counties (favorable) are attributable to the smoking ban, but the observed effects in urban counties (unfavorable) are not. This is clearly post-hoc reasoning that is not consistent with the methods set out in the paper.

The rest of the story is that this study failed to find any effect of the statewide smoking ban on heart attacks among 83% of the population of Arizona, despite the fact that the overwhelming majority of that population was not covered by smoke-free bar and restaurant ordinances prior to the statewide law. The study is thus inconsistent with the conclusions of anti-smoking groups that smoke-free restaurant laws result in an immediate and dramatic decline in heart attacks.

Once again, I would love nothing more than to see documentation of an immediate decline in heart attacks due to smoking bans, since I have devoted a significant portion of my career to working for such laws. However, the existing evidence simply doesn't support such a conclusion. And this study is no exception. In fact, if anything, this study provides evidence that no such effect occurred in response to the Arizona smoking ban.

Of course, this doesn't mean that the smoking bans are not justified. It simply means that anti-smoking advocates should not make false promises about the immediate declines in heart attacks that will result from such policies.

The Campaign for Tobacco-Free Kids has set a new standard for blinding hypocrisy. In a press release issued Tuesday, the Campaign insisted that other nations adopt the provisions of the Framework Convention on Tobacco Control (FCTC) treaty, stating: "To reduce non-communicable diseases, nations must more quickly and effectively implement the cost-effective and scientifically proven measures called for by the international tobacco control treaty, the Framework Convention on Tobacco Control."

The Rest of the Story

What the Campaign for Tobacco-Free Kids fails to mention in its press release is that it lobbied for legislation that violates the terms of the very same treaty (FCTC) that the Campaign is telling other countries they must adhere to.

Upon the Campaign for Tobacco-Free Kids' insistence and as a result of its vigorous lobbying, the United States has violated the World Health Organization's Framework Convention on Tobacco Control (FCTC) treaty by granting the tobacco industry permanent membership on the scientific advisory panel that will help the FDA implement its tobacco regulations.

This violation was first reported by Glantz, Barnes, and Eubanks in their blistering critique of the FDA tobacco legislation (see: Glantz SA, Barnes R, Eubanks SY. Compromise or capitulation? US Food and Drug Administration jurisdiction over tobacco products. PLoS Medicine 2009; 6(7):e1000118).

According to the FDA legislation, the Tobacco Products Scientific Advisory Committee shall consist of two members of the tobacco industry, including one representative of the major tobacco companies and one representative of the smaller tobacco companies.

However, Article 5.3 of the FCTC treaty states: "Parties should not allow any person employed by the tobacco industry or any entity working to further its interests to be a member of any government body, committee or advisory group that sets or implements tobacco control or public health policy."

It is shameful that one of the nation's leading tobacco control groups has led the charge to put the U.S. in violation of the FCTC treaty, especially when that same organization is lambasting other countries for not adhering to the terms of the treaty.

The FDA has been accused of becoming increasingly politicized and losing its pure science focus. This action by the Campaign for Tobacco-Free Kids and other anti-smoking groups makes the problem much worse, as it politicizes decisions regarding the most dangerous product that the FDA is being asked to regulate.

President Obama, in his inauguration speech, said that under his administration, we would "return science to its rightful place." Thanks to the anti-smoking groups which promoted this bill, the politicization of the FDA is institutionalized, rather than resolved.

Not only does the Campaign for Tobacco-Free Kids' agreement to the tobacco industry representation on the advisory committee clause undermine the entire integrity of the FDA, but it also severely undermines the entire field of international tobacco control.

As Glantz et al. write: "The multinational tobacco companies will almost certainly use the precedent in the FDA bill to undermine implementation of the FCTC elsewhere, particularly since leading health advocates in the United States have been publicly defending this provision. Even though the US is not yet a party to the FCTC, US advocates must consider the global public health impacts of their actions here."

Regardless of one's position on the FCTC treaty itself, we should all be able to agree that it would be blinding hypocrisy for the Campaign for Tobacco-Free Kids to insist that the U.S. violate the treaty - on the one hand - and for the Campaign to urge countries across the globe to sign, ratify, and implement the provisions of the treaty, on the other hand.

Yet that is precisely what the Campaign is doing.

The Campaign is waging an initiative to urge countries around the world to ratify and implement the treaty. The Campaign even has an implementation guide on its web site, in which it declares that countries must follow Article 5.3, which is intended to "protect public health policies from tobacco industry influence."

Thus, the Campaign for Tobacco-Free Kids is full of hypocrisy. On the one hand they are telling other countries they must adhere to the FCTC treaty. On the other hand, they negotiated and supported legislation that puts the U.S. in violation of the treaty.

Thus, the rest of the story is that the Campaign for Tobacco-Free Kids knowingly lobbied for a policy to put the U.S. in permanent violation of the FCTC treaty while at the same time demanding that other countries adhere to the policy.

That sets a new standard for hypocrisy that will be hard to beat for generations to come.

Wednesday, May 19, 2010

According to an article in the Boston Globe, the Massachusetts Department of Public Health is set to issue regulations that would require tobacco retailers in the state to post graphic warnings about the perils of tobacco wherever tobacco products are sold, urging their customers not to buy these products. The purchase of the posters would be financed by stimulus money from the federal government.

According to the article: "Massachusetts is poised to become the first state in the nation to force retailers to prominently display graphic warnings about the perils of smoking right where cigarettes are sold — at tobacco sales racks and next to cash registers. Images of ominously darkened lungs, damaged brains, and diseased teeth could start appearing before the end of the year in more than 9,000 convenience stores, pharmacies, and gas stations, if a proposal by the state Department of Public Health is approved as expected. Other posters would direct smokers to where they can get help to stamp out their habit. Retailers who refuse to display the signs within 2 feet of tobacco displays and cash registers could face fines of $100 to $300."

"The campaign is being underwritten by $316,000 in federal stimulus money from the Centers for Disease Control and Prevention, which will allow the state to provide the materials to retailers without charge. Because the posters will be produced by outside vendors, a spokeswoman for the state Department of Public Health said, it conforms to the intent of the stimulus law, providing jobs in a sour economy."

The Rest of the Story

My readers know that I am a strong supporter of anti-tobacco advertising campaigns that discourage kids from starting to smoke and encourage existing smokers to quit. In fact, anti-tobacco advertising is - in my view - the appropriate way for the federal government to address the tobacco problem, rather than wasting its time regulating the ingredients in tobacco products. I would therefore be supportive of any efforts to encourage retailers to voluntarily agree to display tobacco warnings or educational posters to discourage tobacco use.

However, this is not a voluntary campaign. It is a government mandate that stores which sell tobacco must actively discourage their customers from buying the products which they sell. If the state health department believes that tobacco products are so harmful that retailers must be forced to urge customers not to buy their own merchandise, then the state should simply not be allowing these products to be sold. If the state is going to allow stores to sell these products, then I believe it is excessive government intervention to tell stores that they can sell them, but they have to discourage anyone from actually buying them.

Requiring retailers to actively discourage customers from buying their products seems to me to be an unreasonable degree of government intrusion. The reasoning that would support such an intervention would equally apply to all harmful products sold by businesses.

Would it be appropriate for the government to require all grocery stores to put graphic warning posters near the junk food aisle urging customers not to purchase these unhealthy snacks?

Would it be reasonable for the government to require grocery stores to post graphic posters at the soda aisle urging customers not to purchase soda because of the morbidity and mortality caused by obesity, to which soda contributes significantly?

Should tanning salons be required to post disgusting pictures of skin cancers at their entrances, urging potential customers not to enter?

Should wood stove stores be required to post graphic posters depicting the horrible consequences of lung disease, which we know is caused by wood smoke exposure?

It seems to me that if a product is so unsuitable for public consumption that the government must require stores to actively discourage customers from buying their own products, then the government needs to simply prohibit stores from selling that product.

To be clear, I'm not calling on the prohibition of tobacco sales in Massachusetts. But I am arguing that requiring stores to actively discourage customers from buying the products which they legally sell is not an appropriate use of the government's police powers.

If Massachusetts is seriously concerned about reducing tobacco use, it should restore funding to its anti-smoking media campaign, for which there is solid scientific evidence of its substantial effect on cigarette smoking rates in the state. The state should take upon itself the responsibility of discouraging tobacco use, rather than requiring stores which legally sell these products to urge customers to deprive these stores of a livelihood. If the state really wants to show its commitment to reducing tobacco use, it will restore funding to a program which used to be a model for the nation in terms of its proven effect on both reducing youth smoking initiation and promoting adult smoking cessation.

Tuesday, May 18, 2010

If you didn't know any better, you would think that the major, national anti-smoking groups were working with the intention of protecting tobacco company profits, especially those of the largest companies.

The current tobacco control agenda makes absolutely no sense. The Campaign for Tobacco-Free Kids, American Heart Association, American Lung Association, and American Cancer Society have been working for years to promote legislation that institutionalizes and protects existing cigarettes. On top of that, they are doing everything they can to remove far safer products - like electronic cigarettes - from the market.

Ironically, these groups are doing exactly the opposite of what makes sense from a public health perspective.

1. They are trying to force ex-smokers who have quit with the help of vaping to return to cigarette smoking.

2. They have successfully gotten rid of the flavored cigarettes which no youth are smoking and protected the market share of menthol cigarettes which tens of thousands of kids are smoking.

3. They are worried about Camel orbs and other dissolvable tobacco products for which there is no evidence of significant use among youth, but at the same time, they have forced the FDA to give official approval to Marlboro, Camel, and Newport cigarettes - the products which are addicting those youths and ultimately killing them.

Frankly, there is no longer any difference between the agenda that these groups are supporting and that of Philip Morris. And that is a sad thing.

When you wake up every morning to find out that your policy agenda is precisely that of Philip Morris, it should give you pause and cause you to re-think your actions. Unfortunately, that has not happened with the Campaign for Tobacco-Free Kids, American Heart Association, American Lung Association, and American Cancer Society. At this point, they are too far down the road to turn back.

The rest of the story is that these anti-smoking groups have forsaken the health of the public, and instead, are pursuing an agenda which is designed to institutionalize and protect the very products which are addicting our nation's youth and ultimately killing many of them.

Monday, May 17, 2010

In a policy guidance document issued for its constituents, the Campaign for Tobacco-Free Kids, American Heart Association, American Lung Association, and American Cancer Society take issue with the contention that active smoking is more dangerous for you than inhaling vapor from a tobacco-free product that delivers propylene glycol, glycerin, nicotine, and only traces of tobacco-specific nitrosamines, at levels up to 1400 times lower than in cigarettes.

In doing so, these anti-smoking groups have gone further even than Big Tobacco. Even the tobacco companies do not claim that their products are no more hazardous than electronic nicotine delivery systems (e-cigarettes).

Nevertheless, the anti-smoking groups claim that they do not know enough to be able to tell the public that smoking is more hazardous than vaping. According to the policy guidance document: "E‐cigarettes are battery‐powered nicotine inhalation devices that claim to deliver nicotine to the user through a vaporized propylene glycol solution. E‐cigarette manufacturers and retailers are making unproven health claims about their products – asserting that they are safe or safer than traditional cigarettes. ... The health claims being made by e‐cigarette companies are misleading and illegal under federal law."

The anti-smoking groups encourage their constituent groups to promote state laws that ban the sale of electronic cigarettes. Further, they urge their constituents to oppose laws that would prohibit the sale of electronic cigarettes to minors. Only laws that completely outlaw the sale of electronic cigarettes are to be supported: "Our organizations support legislation that would prohibit all sales of e‐cigarettes until these products are approved by FDA. Bans on the sale of e‐cigarettes should prohibit all sales and avoid including e‐cigarettes in youth access laws while at the same time allowing sales to adults to continue."

The Rest of the Story

You have got to be kidding me. These anti-smoking groups do not have enough information to be able to conclude that cigarette smoking, which kills hundreds of thousands of Americans each year, is more dangerous than a device which "delivers nicotine to the user through a vaporized propylene glycol solution."

It doesn't take a rocket anti-smoking group to be able to figure out that inhaling nicotine plus more than 10,000 chemicals - including 60 carcinogens - is more dangerous than inhaling nicotine without those 10,000 plus chemicals and carcinogens. In fact, the very study to which the policy guidance document refers - the FDA laboratory study - confirms that there are only trace levels of carcinogens in electronic cigarette cartridges, comparable to the levels found in nicotine replacement products.

If these anti-smoking groups are not convinced that electronic cigarettes are safer than smoking, then there is no way they should be convinced that the use of nicotine replacement therapy is safer than smoking. After all, the levels of carcinogens in these two types of products are virtually identical. How could it be that nicotine replacement products pose a much lower carcinogenic risk than smoking, while electronic cigarettes don't, if both products contain the same amount of carcinogens?

More disturbing than these groups' apparent scientific incompetence is the fact that they are promoting a policy which would cause severe harm to the public's health. Banning electronic cigarettes would force thousands of vapers who have successfully quit smoking to return to cigarettes. The result? Increased disease and death.

That these groups are urging their constituents to oppose laws to ban the sale of electronic cigarettes to minors is even more appalling. They are willing to sacrifice the health protection of minors in order to promote their ideological position: that the very act of looking like you're smoking is unacceptable, even if by doing so you have become an ex-smoker.

Most disturbing, and unethical, is the fact that these groups - in their policy guidance document - fail to disclose their financial conflict of interest: their receipt of funding from pharmaceutical companies which manufacture smoking cessation medications.

Banning the sale of electronic cigarettes would benefit two major industries: Big Tobacco and Big Pharma. Every electronic cigarette used is one less cigarette smoked and/or one less sale of a nicotine replacement or other smoking cessation pharmaceutical product. Thus, any financial conflict of interest with pharmaceutical companies must be revealed in a policy document which is promoting a ban on the sale of electronic cigarettes. But these organizations have failed to disclose their conflicts of interest.

By promoting bans on electronic cigarettes, the anti-smoking groups are - once again - doing a huge favor for Big Tobacco. Such policies would help protect Big Tobacco profits by ensuring that a product which is being used by many vapers as a very successful strategy for keeping off cigarettes is taken off the market.

The rest of the story is that the anti-smoking groups are apparently more concerned about ideology than about the lives of smokers. Better that ex-smokers who have quit without the aid of Big Pharma products be forced to return to cigarette smoking than that they remain off cigarettes, but continue to go through a motion that looks like cigarette smoking.

Thursday, May 13, 2010

There are at least 12 laboratory studies of the constituents of electronic cigarettes. These studies have characterized the chemical make-up of the liquid used in electronic cigarettes and therefore, provide an indication of the potential exposures of electronic cigarette users. The studies demonstrate, quite convincingly, that these products are far safer alternatives to cigarette smoking. No tobacco is present, there are only traces of tobacco-specific nitrosamines, the main non-nicotine ingredients - propylene glycol and glycerin - are generally recognized as safe, and the tests failed to reveal significant amounts of any chemical that is known to pose substantial health hazards.

However, as I revealed yesterday, the American Lung Association has apparently only considered the results of one of these studies. As I wrote yesterday: According to Connecticut's NBC affiliate, the American Lung Association is telling the public that there has been only one laboratory study conducted on electronic cigarettes: "We asked experts if e-cigs are safer than old-fashioned cigs. Michelle Marichal, of the American Lung Association, said the jury’s still out. 'We're reluctant because there have been no studies done except for one small one by the FDA... ."

Here are links to the additional studies that have characterized the chemical constituents of electronic cigarette cartridges or vapor:

The most disturbing aspect of the American Lung Association's dissemination of misinformation to the public about the relative safety of cigarettes compared to electronic cigarettes (they are equally safe, according to the ALA), is that the Lung Association's public statements are apparently the result of a very skimpy review of the scientific evidence. By its own admission, the ALA has only reviewed one report. Even that report has been misinterpreted, since it actually demonstrates that the levels of the identified tobacco-specific nitrosamines in electronic cigarettes are miniscule. They are comparable to levels found in nicotine replacement products.

I believe that if an organization is going to make public recommendations about an issue as important to people's health as whether or not they are better off using electronic cigarettes than smoking, it has an obligation to first review the available scientific evidence -- all of it, not just the study or studies it believes are favorable to its cause.

The Lung Association's failure to even consider the scientific evidence is particularly shameful because we are talking here about people's lives. If doctors made health recommendations to patients without bothering to review the evidence, it would be malpractice. Public health organizations, I believe, share the same obligation to make health recommendations that are based on the available evidence, rather than on pure speculation or ideology.

The ALA is certainly entitled to interpret the scientific studies differently than me, but to not even look at the studies before making its public recommendations is irresponsible and is a disservice to its constituents and the public.

Wednesday, May 12, 2010

According to Connecticut's NBC affiliate, the American Lung Association is telling the public that there has been only one laboratory study conducted on electronic cigarettes: "We asked experts if e-cigs are safer than old-fashioned cigs. Michelle Marichal, of the American Lung Association, said the jury’s still out. 'We're reluctant because there have been no studies done except for one small one by the FDA, and that was an initial study and what it found is that these e-cigarettes contain carcinogens. They contain toxic chemicals like those found in antifreeze.'"

The Rest of the Story

Sadly, the American Lung Association is making completely uninformed and inaccurate comments on this important public health policy issue. If the ALA wants to comment and try to affect public policy, it has an obligation to first study the issue. Instead, the Lung Association is speaking first and doing so without having even researched the issue. As a result, the ALA is making false statements to the public that are misinforming consumers.

The rest of the story is that there are at least 11 laboratory studies on the constituents and safety of electronic cigarettes, not 1 study as the American Lung Association claims.

These studies have shown that:

1) Only one brand of electronic cigarettes has been found to contain diethylene glycol (a component in anti-freeze); and

2) There are only trace levels of tobacco-specific nitrosamines in electronic cigarettes, comparable to levels in nicotine replacement products.

Thus, the American Lung Association is misinforming consumers about the risk of electronic cigarettes when it states that they contain toxic chemicals like those found in anti-freeze and that they contain carcinogens.

It's true that they contain carcinogens, but so do nicotine replacement products that the Lung Association endorses. The critical issue is the level of those carcinogens. And in electronic cigarettes, tobacco-specific nitrosamine levels are up to 1400 times lower than in cigarettes, making these products a much safer alternative to smoking.

In the past two days, I have criticized the American Lung Association for providing inappropriate advice to electronic cigarette users and for claiming that there is no evidence that cigarette smoking is any more dangerous than vaping. Today, I have revealed perhaps the most troubling fact of all: that the American Lung Association's statement and position are based on a failure to actually look at the scientific evidence.

It would be one thing if the ALA had examined the scientific evidence and disagreed with my interpretation. But to make broad scientific and policy statements without having examined the evidence is irresponsible and it does a great disservice to the ALA's constituents and the public.

Tuesday, May 11, 2010

In a public statement in support of an Illinois bill that would ban the sale of electronic cigarettes, the American Lung Association has stated that there is no scientific evidence that smoking cigarettes is any more dangerous than quitting smoking altogether and using only electronic cigarettes.

In other words, the American Lung Association is telling the public that the use of a product which burns tobacco, produces more than 10,000 chemicals, including more than 40 known carcinogens, and has been shown to cause hundreds of thousands of death each year in the U.S. is no more hazardous than a product which contains no tobacco and delivers only nicotine, glycerin, propylene glycol, and trace amounts of a few other constituents.

The American Lung Association states: "There is no scientific evidence that e-cigarettes are safer for consumers than regular tobacco products."

Along the same lines, the American Lung Association states: "It would be dishonest to let smokers think they are making a positive change by switching to these products rather than quitting."

Once again, the Lung Association is stating that it is just as healthy to smoke cigarettes as it is to quit smoking, if you quit smoking through the use of electronic cigarettes.

The Rest of the Story

With this statement, the American Lung Association has completely lost all scientific credibility.

Even the tobacco companies are not arguing that their products are no more dangerous than electronic cigarettes, which contain no tobacco and have been shown to contain only trace levels of tobacco-specific nitrosamines and no other carcinogens.

It shouldn't take a rocket toxicologist to figure out that a product which delivers nicotine plus more than 10,000 chemicals, including high levels of known carcinogens, is going to be more hazardous than a product which delivers nicotine, without those 10,000 chemicals and carcinogens.

While it is true that the safety of electronic cigarettes has not been documented in epidemiologic studies, laboratory studies have demonstrated that these products are likely to be much, much safer than regular cigarettes. These laboratory studies certainly constitute scientific evidence that these products are safer. Thus, it is incorrect and irresponsible for the American Lung Association to state that there is no scientific evidence that vaping is any less hazardous than smoking.

In contrast to the false statements made by the Lung Association, electronic cigarettes have been studied extensively and their constituents have been carefully characterized by gas chromatography and mass spectrometry in a number of studies. Based on these examinations, there has been only one potentially hazardous exposure identified (diethylene glycol) and so far, that has been found in only one brand of electronic cigarettes. All other brands of electronic cigarettes tested have been negative for diethylene glycol. The other major constituents in electronic cigarettes - propylene glycol and glycerin - are generally recognized as safe. Moreover, in spite of having been on the market for more than three years, there are no known reports of serious adverse effects of these products.

To be honest, how the American Lung Association can state that they are unsure cigarette smoking is any more dangerous than vaping is baffling to me. Not only is it baffling, but it is irresponsible and damaging. According to the Lung Association, smokers who have quit smoking successfully using electronic cigarettes are better off returning to their Marlboros than remaining ex-smokers with the use of electronic cigarettes. Any physician who gave that advice would be doing a great disservice to his or her patients. What the American Lung Association is doing, then, is committing public health malpractice on a massive scale.

Where the American Lung Association tips its hand, and perhaps make its scientifically incompetent statements less baffling, is when it refers to "switching to these products rather than quitting." What the American Lung Association apparently fails to understand is that switching to these products is quitting.

In other words, as far as the Lung Association is concerned, if you go through the motions of what looks like smoking, you are a smoker, even if you have quit smoking and are no longer using tobacco products. It is the act of going through the motions that look like smoking, not the health hazards of those actions, which the American Lung Association is fighting against. Thus, the Lung Association has become blinded by ideology and has lost sight of the actual goal: improving the public's health.

Had the Lung Association stated that there are no epidemiologic studies which have documented that vaping is safer than smoking, that would have been one thing. But to state that there is no scientific evidence at all that vaping is safer than smoking is completely misrepresenting the science that is readily available.

The rest of the story is that not only has the American Lung Association lost its scientific credibility, but it has also lost sight of the goal of protecting the public's health. Instead, it is apparently blinded by ideology. Or perhaps, blinded as well by money. The money it receives from Big Pharma is perhaps another reason why the Lung Association is acting to protect Big Tobacco and Big Pharma profits, rather than the health of the American people.

Monday, May 10, 2010

The American Lung Association (ALA), through both direct statements to consumers and through its policy statements, is urging thousands of ex-smokers in the U.S. to return to cigarette smoking.

Specifically, the Lung Association is urging ex-smokers who have quit smoking by virtue of the use of electronic cigarettes to discontinue use of those devices and return instead to regular cigarettes. While the ALA might argue that it would prefer that these ex-smokers switch from electronic cigarettes to an FDA-approved nicotine replacement therapy or other smoking cessation medication, the reality is that the vast majority of vapers, if they discontinue use of e-cigarettes, will return to cigarette smoking.

In messages received by several vapers who questioned the ALA's support for a ban on electronic cigarettes, the American Lung Association states: "Until the U.S. Food and Drug Administration (FDA) determines that e-cigarettes are safe for consumers, the American Lung Association urges consumers not to use these products."

The ALA is actively working to take electronic cigarettes off the market: "the American Lung Association urges the FDA to act immediately to halt the sale and distribution of all e-cigarettes."

At the same time, the ALA states that it "is committed to helping all Americans who want to break their addiction to nicotine."The Rest of the Story

Baloney.

The American Lung Association is clearly not committed to helping all Americans who want to break their addiction to nicotine. Obviously, it is not committed to helping the thousands of Americans who have successfully broken their smoking addiction by switching from smoking to the use of electronic cigarettes. In fact, it wants those vapers to return to cigarette smoking, rather than using a product which the FDA has not approved, but which is clearly much safer than smoking.

In fact, the American Lung Association's position is that it is better for a vaper to return to smoking than to continue to remain tobacco-free by virtue of using electronic cigarettes. Thus, the American Lung Association's actual position is that it supports smoking cessation, but only if the smoker quits by virtue of pharmaceutical products, not if the smoker quits using electronic cigarettes.

Perhaps the ALA's position is not surprising given the tremendous amount of pharmaceutical company support that it receives. In the second quarter of 2009 alone, the American Lung Association received more than $1.5 million from Pfizer, manufacturer of Chantix and Nicotrol. Moreover, Pfizer is a sponsor of the Lung Association's Freedom from Smoking program.

The financial connection is so strong that the American Lung Association goes so far as to promote Pfizer on its web site, boasting that: "Founded in 1849, Pfizer is the world's premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support. At Pfizer, colleagues in more than 90 countries work every day to help people stay happier and healthier longer and to reduce the human and economic burden of disease worldwide."

In other words, the American Lung Association is allowing Pfizer to gain a huge public relations benefit out of its financial support. It is truly a partnership, not merely a charitable contribution from Pfizer. Clearly, the ALA has become beholden to Pfizer by virtue of the money it has received. No wonder the ALA finds it such a threat that thousands of smokers are quitting by virtue of a product that is not produced by Big Pharma. Electronic cigarettes are a real threat to Pfizer's profits.

Of course, no where on the site does it mention that Chantix has been linked to many serious and even fatal side effects.

Moreover, no where on its web page where it calls for the removal of electronic cigarettes from the market does the American Lung Association disclose that it has a financial conflict of interest by virtue of its receiving millions of dollars of support from Big Pharma. I view that as an unethical failure to disclose a relevant conflict of interest. Furthermore, the American Lung Association even mentions its Freedom from Smoking program on that web page, but fails to disclose Pfizer's financial support.

In an excellent blog post over at "The Truth about Nicotine," VocalEK explains: "I could understand the ALA taking the stance, “Until more is known, the American Lung Association cannot recommend the products.” However, in view of the known negative health consequences of inhaling smoke, it seems unethical to urge consumers not to use the products."

I think this is a critical point. If the American Lung Association had merely stated that it couldn't recommend electronic cigarettes, that would be one thing. But to actively encourage vapers not to use these products is tantamount to urging them to return to active smoking.

Kristin Noll-Marsh also has an excellent blog post in which she criticizes the American Lung Association for failing to recognize that switching to electronic cigarettes is quitting smoking and argues that the ALA is doing public health harm through its position and statements.

The rest of the story is that: (1) the American Lung Association is acting unethically in failing to disclose its financial conflict of interest with Big Pharma in its public statements lobbying for the prohibition of the sale of electronic cigarettes in the United States; and (2) the American Lung Association is no longer fighting for the best interests of the lung health of Americans; it is, instead, fighting for the financial health of the nation's pharmaceutical companies, especially those companies which provide funding to the Lung Association.

Friday, May 07, 2010

According to the American Cancer Society (ACS), quitting or cutting down on smoking by use of electronic cigarettes is not a good thing and harms the public's health.

According to an article in the Washington Post: "A spokesman [of the ACS] said it believes the devices were created to get around smoking bans and violate the spirit of smoking bans. "Allowing them would really be turning back the clock on what we're trying to do in Virginia to create smoke-free workplaces and environments that promote health," said American Cancer Society spokesman Keenan Caldwell."

The Rest of the Story

The American Cancer Society needs, first of all, to get its facts straight. Electronic cigarettes are not tobacco products and therefore, they are not devices which were created to "get around" smoking bans. In fact, electronic cigarettes were created in order to give smokers a safer alternative to the deadly regular cigarettes. In other words, they were created for an inherently health-promoting purpose: getting smokers off cigarettes.

The American Cancer Society needs, second of all, to look at the scientific evidence. There is compelling evidence that electronic cigarettes are being used by many smokers to either quit smoking or at very least, to significantly cut down on the amount they smoke. Thus, these devices are contributing towards a major improvement in the public's health. Moreover, there is strong evidence, based on extensive laboratory testing, that these products are much safer than conventional cigarettes.

What the American Cancer Society appears not to recognize is that every electronic cigarette used is one less cigarette smoked. Actually, it's about 10 less cigarettes smoked because a single cartridge can last for quite a while. In what way is a great reduction in cigarette use not a health-promoting effect?

The problem for the American Cancer Society is, apparently, that while smokers may be quitting or cutting down using e-cigarettes, that quitting is not being done using pharmaceutical products made by companies with which the ACS has a financial arrangement or from which the ACS has received substantial funding.

The American Cancer Society appears not to be inherently concerned about the health of smokers, but instead, to be primarily concerned with whether or not those smokers support the pharmaceutical companies upon which the ACS relies for funding. If a smoker quits using a nicotine inhaler or nicotine patch, it's a great thing. If a smoker quits by switching to vaping, it's a bad thing. Sorry, but that's not supporting health. It's supporting the financial interests of two big industries: Big Pharma and Big Tobacco.

The American Cancer Society should be ashamed of itself for telling the nation's vapers that cutting down significantly on smoking or quitting smoking entirely is bad for their health and that it doesn't promote improved health in the nation. But what they should be even more ashamed of is that their financial conflict of interest with Big Pharma, undisclosed in any of these articles, is shaping their public position and leading to advice that is going to substantially harm the public's health.

Thursday, May 06, 2010

The Nevada legislature thought it was doing a great thing when it decided to fund a college scholarship program using revenues from the state's tobacco settlement with the major cigarette companies. The Millennium Scholarship program has allowed thousands of Nevadans to go to college who would not otherwise have been able to afford a higher education.

Now, however, the program is threatened, due in part to declining cigarette revenues and therefore, declining tobacco settlement funding.

According to an article in the Reno Gazette Journal: "The Millennium Scholarship program began with great promise a decade ago, when then-Gov. Kenny Guinn proposed using a portion of the money due to the state from the national tobacco settlement fund to fund scholarships for Nevada's brightest high-school students. (The rest of the settlement money was to be used for a variety of health programs.) Guinn reasoned that college graduates were less likely to smoke than non-graduates, so it made a certain sense to use tobacco money to fund the program. More important, Guinn recognized that good students who stay in the state are more likely to remain in the state after graduation, helping to boost an economy in dire need of more college graduates."

The Rest of the Story

While using cigarette tax revenues to fund important government programs may seem like a wise thing to do initially, this story demonstrates the folly of this approach. Eventually, the declining cigarette tax revenue is going to threaten the solvency of these programs. Making important government programs dependent upon continuing cigarette sales is not only bad fiscal policy, it runs counter to public health goals and incentives. It is not appropriate for the government to rely upon high rates of cigarette consumption to fund essential programs. It creates a need for continued smoking, removes any incentive for the state to reduce cigarette consumption, and unfairly balances the budget on the backs of smokers.

Wednesday, May 05, 2010

The Campaign for Tobacco-Free Kids is praising the new, larger warning labels on smokeless tobacco advertisements, but scientific evidence shows that these labels will have little effect on health, but will have a huge effect in helping to immunize the tobacco industry from liability in litigation.

According to an article in the New York Times: "Magazine readers no longer have to squint to see the health warning on ads for smokeless tobacco products. Big, bold health warnings, which stem from last year’s landmark tobacco law, have begun showing up in magazines this month. The new rules requiring more prominent health warnings on advertising for smokeless tobacco products officially go into effect June 22 and kick in a year later for cigarette ads. Previously, the warning on smokeless tobacco ads appeared in a small circle in the corner of the ad. Now the bold warning must fill 20 percent of the advertising space. “A huge improvement,” said Matthew L. Myers, president of the Campaign for Tobacco-Free Kids, a Washington interest group. “You can’t miss the new warnings, whereas the old warnings disappeared into the ad and were virtually invisible.”"

The Rest of the Story

The "evidence" cited in the article to support the contention that these larger warning labels will substantially reduce tobacco use is an article published in the MMWR, which reviews the issue of warning labels. However, that article provides no evidence that these labels actually reduce tobacco use. They simply review which countries have implemented what types of warning labels.

In fact, the research evidence shows that small warning labels, like the 20% size labels now required by the FDA tobacco law, have virtually no effect on product use. People quickly become used to the labels and then ignore them. In fact, brain imaging studies have shown that over time, people begin to see the labels as simply part of the ad, and the labels themselves become a stimulus for product usage.

The one effect which these warning labels will have, however, is to completely immunize the tobacco industry against litigation. No jury is going to find the tobacco companies responsible, or even partly responsible, for damage caused by their products when these companies can argue that consumers are adequately warned of the product's dangers by virtue of these large warning labels.

Tuesday, May 04, 2010

In a great victory for evidence-blind policy, Senators Sherrod Brown (D-OH) and Jeff Merkley (D-OR) have called for dissolvable tobacco products to be immediately pulled from the market because they claim these products are being used to hook youth.

According to an article in the Columbus Dispatch: "To the average school nurse, teacher or security officer, they might well pass as innocent packages of breath mints. That's a big reason "dissolvable tobacco" products such as Camel Orbs are so attractive to youths trying to pull a fast one on adults while still getting a significant hit of nicotine, says Kate King, a school nurse in central Ohio. "My big concern is we don't see them they are below the radar," said King, president-elect of the Ohio Association of School Nurses. "It's an easy thing. It's a cute package. They are easily concealable."

"That attraction to teenagers, as well as potential health dangers to children cited in a study last month, is why Sen. Sherrod Brown wants federal regulators to immediately remove such material from the market. "Dissolvable tobacco products are being used to hook youth and sustain nicotine addiction," Brown said in an April 21 letter, co-written with Sen. Jeff Merkley, D-Ore., to FDA Commissioner Margaret Hamburg. ... Brown and Merkley told Hamburg, "Given the compelling new evidence in this study that these new tobacco products pose an immediate and significant health risk to children, we urge the FDA to take action right away to keep tobacco candy products off store shelves and out of the hands of children."

The Rest of the Story

The following is a complete account of the evidence that Senators Brown and Merkley rely upon to support their contention that dissolvable products are hooking youth and creating or sustaining nicotine addiction among minors:

No, you didn't miss anything. There is no evidence that these products are hooking youth and creating or sustaining nicotine addiction.

Even the federal Office on Smoking and Health acknowledged that there is no evidence that youths are using these products: "There are limited data on youths and dissolvable tobacco products" ... said Dr. Terry Pechacek, associate director for science at the U.S. Centers for Disease Control and Prevention's Office on Smoking and Health."

For those who don't speak federal bureaucratese, "There are limited data" translates into: "There is no actual evidence that youths are using dissolvable tobacco products."

I've heard of race-blind policies and need-blind policies, but evidence-blind policy making is not exactly what we should be striving for. Yet that is exactly what has overtaken the tobacco control movement, especially at the federal level.

Ironically, while Senators Sherrod and Merkley pretending to protect the health of the nation's children by removing from the market a product which very few of those youths actually use, these same Senators voted for legislation which protects and institutionalizes the addiction of those very same children with regular cigarettes, a product which millions of these youths are actually using. Sherrod and Merkley are so concerned about products which kids aren't using that they've completely lost sight of the products which are actually endangering the lives of an entire generation of youths: namely, Marlboros, Camels, and Newports.

If Senators Sherrod and Merkley truly want to do something to protect our nation's youth, they will have to do something about cigarettes - and I'm talking about the real ones. Unfortunately, doing so would require them to actually go up against Philip Morris, something they apparently don't have the political courage to do.

Monday, May 03, 2010

If the protection were of the public's health, it would be a great thing. But instead, the only protection offered by the FDA tobacco law is protection of the profits of the biggest of Big Tobacco.

With the FDA and the Act already under siege through a series of lawsuits against the constitutionality of the law's advertising and communication restrictions, the Agency was sunk deeper into a swamp of litigation last week with the filing of a new lawsuit, this one by three small tobacco companies which are claiming that the Act poses unconstitutional restrictions on their commercial speech in a way that threatens their ability to survive as businesses.

As summarized in their Complaint, the three tobacco companies claim that: "The FDA is seeking to impose draconian restrictions on the ability of cigarette manufacturers to engage in commercial speech using their federally-registered trademarks, including brand names that have been in use for years. As explained below, the regulation violates the Free Speech Clause of the First Amendment as well as the Due Process Clause and Takings Clauses of the Fifth Amendment."

The lawsuit relates to a little-noticed clause in the Family Smoking Prevention and Tobacco Control Act, which states: "A manufacturer shall not use a trade or brand name of a nontobacco product as the trade or brand name for a cigarette or smokeless tobacco product, except for a tobacco product whose trade or brand name was on both a tobacco product and a nontobacco product that were sold in the United States on January 1, 1995."

One of the plaintiffs - Renegade Tobacco - produces cigarettes with brand names of Tucson, Tracker, and Barton and has registered trademarks for each of these brands of cigarettes. However, subsequent to the introduction of these products, these same brand names have been used for nontobacco products (automobiles, computers, and alcoholic beverages, respectively). Thus, according to the Act, Tucson, Tracker, and Barton cannot be used as cigarette brand names by Renegade and its products with these brand names must be taken off the market.

Not coincidentally, the top six cigarette brands in the U.S., all manufactured by Big Tobacco companies, are protected by the Act's exemption for products that were used as both a tobacco and nontobacco brand name in 1995. For example, Marlboro merchandise was being sold in the U.S. in 1995, so if any non-tobacco product comes on the market with the Marlboro name, Marlboro products are protected. The same protection holds for Camel, Newport, Winston, Doral, Basic and according to the lawsuit - nearly every brand name being used by the three major tobacco companies. Thus, at least 90% of the market is protected by this exemption, while the market of cigarettes produced by minor companies is at risk.

The plaintiffs argue that this provision of the Act violates the First Amendment of the Constitution because it infringes upon their free speech rights. Specifically, the provision violates the first prong of the Central Hudson test because there is no substantial government interest in ensuring that otherwise lawful and non-misleading brand names be taken off the market.

The Rest of the Story

I believe that the plaintiffs have a very strong case. Before explaining why, let me demonstrate why this provision of the Act represents a protectionist law that has no public health basis, but serves only to protect Big Tobacco profits.

This provision all but ensures that the major tobacco companies can eliminate any competition from the smaller companies. To do this, they simply have to market nontobacco products with the brand names of their competitors.

In other words, all Philip Morris has to do if it wants to eliminate competition from minor tobacco companies is find out the brand names of all the brands these companies are marketing and introduce nontobacco products with those brand names. Unless there were already nontobacco products with those brand names in 1995, those brands will have to be taken off the market, or renamed.

But if they are renamed, then all Philip Morris has to do is introduce another nontobacco product with the new brand name. Essentially, then, the smaller tobacco companies are prohibited from selling any cigarettes.

If the minor companies try to get around this by using as a cigarette brand name the name of a nontobacco product that was on the market in 1995, that doesn't work. Why? Because the name needs to be the brand name of both a nontobacco and a tobacco product in 1995.

This is as protectionist a piece of legislation as I've ever seen. The impact of this provision is merely to prevent smaller tobacco companies from continuing to compete in the marketplace, and to protect the market share of all but the largest tobacco companies.

Moreover, there is no public health justification or aim for this provision. It neither serves nor advances any public health purpose.

One might argue that the government has an interest in preventing companies from marketing branded non-tobacco merchandise because this could promote smoking, especially among youth (I have in fact conducted research myself which documents this assertion). However, the legislation does not advance this interest, because it exempts specifically those brands which were being marketed via nontobacco merchandise. Moreover, it would certainly fail the 4th prong of Central Hudson because it is far broader a restriction than would be necessary to address this concern.

The rest of the story is that like many provisions in the Act, this one serves no legitimate public health purpose. It serves solely to protect the interests and profits of Big Tobacco, especially the largest and most dominant tobacco company: Philip Morris.

And it is for that reason that the provision violates the First Amendment. Since it does not serve to advance any legitimate government interest, it fails the first prong of Central Hudson. One need go no further than that.

While it is the FDA that is going to have to defend itself in the courts in all these lawsuits, it is the health groups which got the FDA into this mess. By supporting legislation which was aimed primarily to protect the dominant market interests of Philip Morris, rather than to protect the public's health, the Campaign for Tobacco-Free Kids and other anti-smoking groups ended up supporting what is clearly unconstitutional legislation, and which will slowly and gradually be emasculated by the federal courts.

Were there any justice, the Campaign for Tobacco-Free Kids would be forced to pay the litigation costs involved in defending these lawsuits.

About Me

Dr. Siegel is a Professor in the Department of Community Health Sciences, Boston University School of Public Health. He has 32 years of experience in the field of tobacco control. He previously spent two years working at the Office on Smoking and Health at CDC, where he conducted research on secondhand smoke and cigarette advertising. He has published nearly 70 papers related to tobacco. He testified in the landmark Engle lawsuit against the tobacco companies, which resulted in an unprecedented $145 billion verdict against the industry. He teaches social and behavioral sciences, mass communication and public health, and public health advocacy in the Masters of Public Health program.